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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device needle, aspiration and injection, disposable
Regulation Description Manual surgical instrument for general use.
Product CodeGAA
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANCHOR PRODUCTS CO.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
E-Z-EM, INC.
  SUBSTANTIALLY EQUIVALENT 1
FERRIS MFG. CORP.
  SUBSTANTIALLY EQUIVALENT 1
HAEMONETICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 2
KIRWAN SURGICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MANAN MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDICAL DEVICE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
NORTHGATE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
RADI MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
Symbiosis Corp.
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
  SUBSTANTIALLY EQUIVALENT 3
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Break 30
Detachment of device component 12
Needle, separation 6
Device operates differently than expected 5
Device, or device fragments remain in patient 5
Tip breakage 3
No Known Device Problem 3
No code available 2
Migration of device or device component 2
Device handling issue 1
Packaging issue 1
Not Applicable 1
Difficult to advance 1
Device remains implanted 1
Use of Device Issue 1
Improper or incorrect procedure or method 1
Unknown (for use when the device problem is not known) 1
Contamination during use 1
Difficult to deploy 1
Total Device Problems 78

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 1 1 2 1 0 1 0 1 0
Class III 0 1 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Company II Oct-07-2010
2 Cadence Inc. II Aug-10-2015
3 First Aid Only Inc III Feb-19-2008
4 Inrad, Inc II Feb-08-2011
5 Medical Device Technologies, Inc. II Jul-13-2010
6 Medical Device Technologies, Inc. II Sep-25-2008
7 SpineNet II Aug-27-2013
8 Vital Signs Inc II Sep-08-2009

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